BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 4-LUMEN 8.5FR X 20CM

    MDR report key: 10101558 · Received May 29, 2020

    Report

    Report Number
    3006425876-2020-00472
    Event Type
    Malfunction
    Date Received
    May 29, 2020
    Date of Event
    May 14, 2020
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED ONE INTRODUCER NEEDLE FOR ANALYSIS. SIGNS-OF-USE IN THE FORM OF BIOLOGICAL MATERIAL WAS OBSERVED. VISUAL OR MICROSCOPIC ANALYSIS DID NOT REVEAL ANY DEFECTS TO THE INTRODUCER NEEDLE. THE NEEDLE LENGTH (PER MEASUREMENT A IN THE INTRODUCER NEEDLE GRAPHIC) MEASURED 2.719", WHICH IS WITHIN THE SPECIFICATION LIMITS OF 2.657"-2.727". THE INTRODUCER NEEDLE INNER DIAMETER MEASURED .041", WHICH IS WITHIN THE SPECIFICATION LIMITS OF .041"-.043" PER THE CANNULA GRAPHIC. THE INTRODUCER NEEDLE OUTER DIAMETER MEASURED .050", WHICH IS WITHIN THE SPECIFICATION LIMITS OF .0495"-.0505" PER THE CANNULA GRAPHIC. THE RETURNED NEEDLE WAS ATTACHED TO A LAB INVENTORY ARS. THE SUBASSEMBLY WAS USED TO DRAW AND ASPIRATED WATER. NO LEAKS OR ANY OTHER DEFECTS WERE OBSERVED. THE NEEDLE CANNULA APPEARED TO BE SECURE WITHIN THE NEEDLE HUB. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS IDENTIFIED. THE REPORTED COMPLAINT THAT THE INTRODUCER NEEDLE HUB WAS CRACKED COULD NOT BE CONFIRMED THROUGH COMPLAINT INVESTIGATION. VISUAL AND MICROSCOPIC EXAMINATION DID NOT REVEAL ANY DEFECTS OR ANOMALIES. ADDITIONALLY, THE INTRODUCER NEEDLE MET ALL RELEVANT DIMENSIONAL AND FUNCTIONAL REQUIREMENTS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT MANUFACTURING ISSUES WERE IDENTIFIED. BASED ON THE CUSTOMER REPORT AND THE SAMPLE RECEIVED, NO PROBLEM WAS FOUND WITH THE RETURNED SAMPLE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "WHEN INSERTING THE CANNULA, AIR WAS DRAWN FOR NO APPARENT REASON."

    Additional Manufacturer Narrative · 1

    QN#: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "WHEN INSERTING THE CANNULA, AIR WAS DRAWN FOR NO APPARENT REASON."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563769 CVC SET: 4-LUMEN 8.5FR X 20CM CATHETER, INTRAVASCULAR, THERAPEUTIC FOZ ARROW INTERNATIONAL INC. IPN031665 71F20A0444

    Patients

    Seq Age Sex Outcome Treatment
    1